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The level of formality in change control may be holding back your SOP progress, according to Siegfried Schmitt, principal consultant at PAREXEL.
Q: We have one established change control process, and this process is applied to all planned changes, including changing standard operating procedures (SOPs). On average, it takes far too long to complete the process. For example, just preparing a line-by-line description of the rationales for each individual change in the text of the SOP can take several weeks. The result is that we often have to operate according to draft versions of SOPs, as changes must be implemented faster for operational or safety reasons. How can we expedite this process?
A: You have correctly interpreted the regulations, which require you to establish change control, or as International Council for Harmonization (ICH) Q10 calls it, change management (1), and to have documented procedures, most likely in the form of SOPs (2). The issue seems to lie in the way change control is applied (i.e., the level of formality).
A formal change control process, which as you describe can take weeks or months to complete (e.g., for the replacement of a filling line), typically consists of these steps:
• Change request
• Feasibility assessment
• Technical review
• Input by regulatory affairs
• Review by quality assurance (QA)
• Approval of change
• Implementation of change
• Verification of change effectiveness
• Close-out of the change request.
Notwithstanding the formality of the process, a change control process should be effective (1), meaning it is user-friendly, simple, and with minimal cycle time for decisions. This is aligned with the concept in ICH Q10 that the level of effort and formality should be commensurate with the level of risk.
Your example of preparing a line-by-line description of the rationales for each individual change in the text of the SOP gives a good idea of the level of formality you apply at present. A change to a SOP will be requested by the owner of the procedure covered by the SOP. So this person needs this change and is thus in a position to assess the technical and operational feasibility of the change very well. More importantly, the requester is perfectly well aware of the reasons (i.e., the rationale for each change in the document). For these reasons, it is standard industry practice to provide a summary rationale, not a line-by-line explanation in the revised document (e.g., change due to revision in the applicable regulations).
It is also easy for reviewers to see changes to the revised draft document as these are created with word processors in ‘track changes’ mode. This normally provides sufficient information for the reviewers and approvers. One issue often encountered at this step in the change process is the number of reviewers and approvers that have to sign off on the document. In effective organizations, this is kept to a minimum (i.e., two or three signatures).
The solution to your problem is to review the level of formality applied, especially in the documentation of the change and the reasons for the change. There is no reason why a change to a SOP cannot be completed in a compliant, controlled, and formal manner in as short a time as one working day.
1. ICH, Q10 Pharmaceutical Quality System (ICH, June 2008).
2. European Commission, EudraLex Volume 4, Part I, Chapter 4 Documentation.
Volume 41, Number 11
When referring to this article, please cite it as S. Schmitt, “Change Control for Standard Operating Procedures" Pharmaceutical Technology 41 (11) 2017.